Background and objectives: Exercise can be used to treat mild to moderate depression. Although previous studies have shown that aerobic exercise may have a therapeutic effect on patients with bipolar disorder, no studies have reported on the effect of aerobic exercise on cognitive function in this patient group. This clinical trial will explore the effects of aerobic exercise on cognitive function in patients with bipolar disorder.
Participants and methods: This parallel randomized controlled clinical trial will be conducted at The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China. A total of 210 bipolar disorder patients will be recruited and randomly assigned to an aerobic exercise group or a control group (n = 105). In the aerobic exercise group, the patients will perform 30 minutes of bicycling, 4 days per week, for 30 consecutive days. The exercise intensity will be 50–70% of the maximum heart rate (220–age). In the control group, the patients will perform recreational activities with a normal intensity, such as making handicrafts, reading, singing, and walking, for 30 minutes, 4 days per week, for 30 consecutive days. This trial was designed in June 2017 and was approved by the Ethics Committee of the Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital), China on July 24, 2017 (approval No. 2017026). Patient recruitment began on December 1, 2017 and will be finished in November 2020. This trial will be complete in December 2020. Protocol version (1.0).
Outcome measures: The primary outcome measure will be the improvement in the MATRICS Consensus Cognitive Battery (MCCB) score 12 months after the exercise intervention. The secondary outcome measures will be the MCCB score at baseline and at a 3-month follow-up assessment, the recurrence rate at 12 months, depressive and manic symptoms at baseline, 4-week, 4-month, and 12-month follow-up assessments, and the incidence of adverse events within 12 months of the follow-up assessment.
Discussion: This clinical trial will provide evidence regarding the effect of aerobic exercise on cognitive impairment in patients with bipolar disorder.
Trial registration: This trial had been registered in the ClinicalTrials.gov (identifier: NCT03353337) on November 27, 2017.